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NSW Genetic Health Guidelines - Part A: The Guidelines

GUIDELINES FOR THE USE OR DISCLOSURE OF GENETIC INFORMATION WITHOUT CONSENT

The Guidelines are presented here for easy reference. The Guidelines provide a concise outline of the requirements for acting in accordance with Health Privacy Principles 10(1)(c1) and 11(1)(c1). They should be read in conjunction with the full explanation; page references are provided in brackets.

For the purposes of Health Privacy Principles 10(1)(c1) and 11(1)(c1):

Guideline 1

Use or disclosure of genetic information without consent may proceed only when the authorising medical practitioner has a reasonable belief that this is necessary to lessen or prevent a serious threat to the life, health or safety of a genetic relative.

(pp 21-31;

in particular

pp 26-29)

Guideline 2

Specific ethical considerations must be taken into account when making a decision about whether or not to use or disclose genetic information without consent.

(pp 15-20)

Guideline 3

Reasonable steps must be taken to obtain the consent of the patient or his or her authorised representative to use or disclose genetic information.

(pp 22-26)

Guideline 4

The authorising medical practitioner should have a significant role in the care of the patient and sufficient knowledge of the patient’s condition and its genetic basis to take responsibility for decision-making about use or disclosure.

(pp 25-26)

Guideline 5

Prior to any decision concerning use or disclosure, the authorisingmedicalpractitioner must discuss the case with other health practitioners with appropriate expertise to assess fully the specific situation.

(pp 26-29)

Guideline 6

Where practicable, the identity of the patient should not be apparent or readily ascertainable in the course of inter-professional communication.

(p 26)

Guideline 7

Disclosure to genetic relatives should be limited to genetic information that is necessary for communicating the increased risk and should avoid identifying the patient or conveying that there was no consent for the disclosure.

(p 31)

Guideline 8

Disclosure of genetic information without consent should generally be limited to relatives no further removed than third-degree relatives.

(p 32)

Guideline 9

All stages of the process must be fully documented, including how the decision to use or disclose without consent was made.

(p 32)

EXPLANATION OF TERMS USED IN THE GUIDELINES

A number of key terms are used in these Guidelines. Most of these are not defined in the HRIP Act. To aid readers, the way in which certain terms are used in these Guidelines is explained below. These explanations are included to assist clarity and do not constitute an interpretation of the legislation. Where a word or phrase is used in its defined sense, the word or phrase will appear in bold in these Guidelines. Otherwise the word or phrase should be interpreted according to its ordinary meaning.

Authorised representative

Authorised representative refers to the person authorised to act on behalf of a patient in relation to matters under the HRIP Act if the patient lacks capacity and means (as defined under section 8(1) of the HRIP Act):

a) an attorney under an enduring power of attorney; or
b) a guardian under the Guardianship Act 1987 or a person responsible within the meaning of Part 5 of the Guardianship Act; or
c) a person having parental responsibility if the individual is a child, or
d) a person who is otherwise empowered under law to exercise any functions as an agent of or in the best interests of the individual.

Authorising medical practitioner

While a range of professionals may be involved in the care of a particular patient, final responsibility for decision-making on behalf of an organisation about use or disclosure should be taken by a person in the organisation who is a senior medical practitioner who has a significant role in the care of the patient, sufficient knowledge of the patient’s condition and its genetic basis and who has sought expert advice. This person may be a specialist or general practitioner as long as the criteria are met.

Cascade contact

A step-by-step process that can provide access to genetic information for a wider cross-section of a family, in which each genetic relative who is notified about their increased risk and makes contact with the disclosing health practitioner, is asked for consent to contact his or her genetic relatives. When additional genetic relatives make contact, the process is repeated.

Confidentiality

The general non-legal principle concerned with the obligation of people not to use private information – whether private because of its content or the context of its communication — for any purpose other than that for which it was given to them (definition from the National Statement on Ethical Conduct in Human Research; NHMRC, ARC & AVCC 2007b).

Disclosing health practitioner

Once a decision has been made that disclosure without consent is necessary, the process of disclosure can be undertaken by the authorising medical practitioner. In these circumstances, the authorising medical practitioner will be the disclosing health practitioner. Alternatively, the authorising medical practitioner can identify another suitably experienced and qualified professional to make the disclosure without consent (e.g. a genetic counsellor). In these circumstances, the person identified will be the disclosing health practitioner.

Duty of confidentiality

It is common for a person to disclose information to another person with the intention that the information will only be used for a particular purpose, particularly in a health practitioner/patient relationship. In these circumstances the common law (the law developed through decisions of courts rather than through legislation) recognises that an obligation or duty of confidence may arise and that the confidential information can only be used or disclosed with the consent of the party who communicated the information.

Note: The duty of confidentiality is in addition to the obligations set out in the HRIP Act.

Genetic information

Genetic information refers to “health information” as described in section 6(d) of the HRIP Act. Genetic information is defined as: “other personal information that is genetic information about an individual arising from a health service provided to the individual in a form that is or could be predictive of the health (at any time) of the individual or of a genetic relative”.

Genetic relative

The term is defined as follows in the HRIP Act as: “a person who is related to an individual by blood, for example, a sibling, parent or descendant of the individual”.

In the context of these Guidelines, disclosure without consent is generally recommended to relatives no further removed than third-degree relatives,[1] as the process of cascade contact should facilitate access to information for the wider cross- section of a family[2].

Lessen

The term “lessen’, as used in HPP 10(1)(c1) and 11(1)(c1) requires an authorised person to form a reasonable belief that the contemplated use or disclosure of genetic information would reduce the serious threat that exists to an individual’s life, health or safety. In circumstances where a contemplated use or disclosure would not reduce a serious threat to life, health or safety, or assist in reducing that threat, the exception as described in HPP 10(1)(c1) and 11(1)(c1) will not apply.

Life, health or safety

The phrase “life, health or safety’, including as it is used in HPP 10(1)(c1) and 11(1)(c1), ordinarily refers to both physical or psychological/emotional health.

Necessary

“Necessary” is defined by the Macquarie Dictionary to mean “something necessary, indispensable, or requisite”. Applying this ordinary meaning in the context of HPP 10(1)(c1) and 11(1)(c1), it can be said that use or disclosure of genetic information will be “necessary” when it is requisite to achieving the stated outcome. Deciding whether disclosure is “necessary” should therefore be based on whether it will lead to the intended outcome, that is, whether disclosure will lessen or prevent a serious threat to life, health or safety. See Section 3.3.3.

Organisation

“Organisation” means a NSW public sector agency, including a public health organisation, or a private sector person.

Privacy

Privacy may refer to having a sense of personal freedom, having information about oneself used fairly and to be left alone. While there is no general legal right to privacy, legislative protection in NSW is provided through the operation of the Privacy and Personal Information Protection Act1998 (PPIP Act) governing the collection, retention, security, access to, alteration, use and disclosure of personal information by NSW public sector agencies. The HRIP Act affords further protection of individuals’ health information, applying to NSW public sector agencies, private health practitioners and businesses in NSW (eg. general practitioners, optometrists, dentists, private hospitals, insurance companies, airlines and medical centres).

Reasonable belief

“Reasonable belief” is a belief that results from the exercise of sound judgement. If an organisation sought to rely on “reasonable belief” they would need to be able to explain, drawing on their experience, training and expertise, the basis on which they formed that belief.

Serious threat

In the context of these Guidelines, there must be a reasonable belief by experts in the field that the threat reflects a significant danger to the individual, which may or may not be imminent. This could include a potentially life-threatening situation, or one that might result in an illness or injury or the threat of a disease or psychological harm that may result in death or disability without timely decision or action.

Use or disclosure

The “use” of genetic information refers to the sharing of genetic information within an organisation, and “disclosure” refers to the sharing of information outside an organisation (e.g. with the patient’s genetic relatives).

Footnotes

[1] Third-degree relative has been chosen for practical reasons e.g. for later onset/potentially fatal disorders like familial cancer it is possible that first and second-degree relatives are deceased and so specifying third-degree relatives gives health professionals the scope needed to reach other relevant family members.

[2] According to the United Kingdom’s NHS National Genetics and Genomics Education Centre, a third-degree relative is defined as “a first cousin, great-grandparent or great-grandchild. A third degree relative shares about one eighth of their genes with the person”. See geneticseducation.nhs.uk/genetics-glossary/242-third-degree-relative(link now deactivated)